FDA Fast Tracks Stem Cells for Crohn’s Disease

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By Douglas A. McIntyre Published
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Osiris Therapeutics (OSIR) was notified that its PROCHYMAL received FDA ‘Fast Track’designation, expediting thedevelopment of the stem cell treatment for Crohn’s Disease that fails to respond to standard therapies.   This takes it to Phase III clinical trials, which will be the last trial stage prior to seeking FDA Approval if resukts are successful.  OSIR shares are up almost 5% at$26.30 in after-hours and shares traded 3-times normal volume; the 52 week trading band is $9.84 to $27.93. OSIR is a recently public company that is up some 150% since the August IPO and its market cap is $685 now million before the after-hours pop.  Jefferies just downgraded this on valuation to a Hold last week, so much of this may already be refelcted in today’s prices.

Jon C. Ogg
January 8, 2007

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About the Author Douglas A. McIntyre →

Douglas A. McIntyre is the co-founder, chief executive officer and editor in chief of 24/7 Wall St. and 24/7 Tempo. He has held these jobs since 2006.

McIntyre has written thousands of articles for 24/7 Wall St. He is an expert on corporate finance, the automotive industry, media companies and international finance. He has edited articles on national demographics, sports, personal income and travel.

His work has been quoted or mentioned in The New York Times, The Wall Street Journal, Los Angeles Times, The Washington Post, NBC News, Time, The New Yorker, HuffPost USA Today, Business Insider, Yahoo, AOL, MarketWatch, The Atlantic, Bloomberg, New York Post, Chicago Tribune, Forbes, The Guardian and many other major publications. McIntyre has been a guest on CNBC, the BBC and television and radio stations across the country.

A magna cum laude graduate of Harvard College, McIntyre also was president of The Harvard Advocate. Founded in 1866, the Advocate is the oldest college publication in the United States.

TheStreet.com, Comps.com and Edgar Online are some of the public companies for which McIntyre served on the board of directors. He was a Vicinity Corporation board member when the company was sold to Microsoft in 2002. He served on the audit committees of some of these companies.

McIntyre has been the CEO of FutureSource, a provider of trading terminals and news to commodities and futures traders. He was president of Switchboard, the online phone directory company. He served as chairman and CEO of On2 Technologies, the video compression company that provided video compression software for Adobe’s Flash. Google bought On2 in 2009.

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